Control Male Condoms of Natural Rubber Latex
510(k) K003375
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK003375 | Date28 Jan 2001 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- LTZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5310
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a Condom With Nonoxynol-9, classified as a barrier contraceptive designed to prevent pregnancy and sexually transmitted infections. Manufactured from natural rubber latex, it provides a physical barrier during sexual intercourse to reduce the risk of sperm entry into the female reproductive tract. The product adheres to regulatory standards for contraceptive devices, ensuring reliability and safety in use.
The Control Male Condoms are supplied as single-use items, intended for one-time application per act of intercourse. They are classified under Device Class II and comply with FDA 510(k) clearance and MDD (Medical Device Directive) requirements. Available in multiple sizes and registration numbers (e.g., 3003592318, 3008808138), these condoms are distributed in sterile packaging for immediate use. No special storage conditions are specified beyond standard room temperature.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of these condoms and how do they work?
These condoms are designed as a barrier contraceptive to prevent pregnancy and reduce the risk of sexually transmitted infections (STIs). They work by creating a physical barrier during sexual intercourse, blocking sperm from entering the female reproductive tract. The product is made from natural rubber latex and includes nonoxynol-9, a chemical that may further inhibit sperm motility and potentially reduce STI transmission. They are intended for single-use per act of intercourse.
Are these condoms sterile and how should they be stored?
Yes, these condoms are supplied in sterile packaging for immediate use. No special storage conditions are required beyond keeping them at standard room temperature. The packaging ensures sterility until opening, making them ready for use without additional preparation.
Are these condoms reusable or meant for single-use, and what sizes are available?
These condoms are single-use only, designed for one-time application per act of intercourse. They come in multiple sizes, as indicated by various registration numbers (e.g., 3003592318, 3008808138, etc.). The exact sizing details (e.g., length, width) are not specified in the data, but the availability of multiple registration numbers suggests variations to accommodate different user preferences.
What regulatory pathways have these condoms followed, and which committees were involved?
These condoms have undergone FDA 510(k) clearance and comply with the Medical Device Directive (MDD) in Europe. The Obstetrics/Gynecology (OB) Advisory Committee reviewed the submission, and the device was classified as Substantially Equivalent (SE) to a predicate product. The Abbreviated 510(k) pathway was used, meaning the manufacturer demonstrated that the device was not significantly different from an already cleared product.